Mindfulness Therapy for Chronic Migraine

NCT03671681 | Completed Phase 4

• 1 other identifier: Mind-CM
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

Brief Summary

The aim is to assess the efficacy of adding on a Mindfulness-based therapy to pharmacological prophylaxis (experimental group: pharmacological prophylaxis + Mindfulness) against pharmacological prophylaxis only (control group) on the reduction of monthly headaches frequency (primary endpoint), symptomatic medications intake, inflammatory pattern, depression, anxiety, cutaneous allodynia, improving disability and quality of life (secondary endpoints). Moreover, other aims are to assess whether adding on Mindfulness-based therapy is also associated to a superior improvement of neuroimaging pattern among patients prescribed neuromodulators or antidepressants and to assess the cost-efficacy of adding on a Mindfulness-based therapy to pharmacological prophylaxis. Mindfulness will be provided in small groups (5-7 patients each) by specifically trained therapists. The treatment consists in six 45 minutes weekly sessions in which one will work on meditation, acceptance and awareness. The program of control group will consist in education of patients, followed by pharmacological prophylaxis. Prophylaxis is prescribed based on patients' profile, such as previous failures, contraindications and so on by a neurologist with expertise in headache treatments. We expect that adding-on Mindfulness will determine a wider reduction of headaches frequency and improvement of secondary endpoints, and that disease cost reduction will support the cost-efficacy of Mindfulness. The study will be a Phase III; randomized, Open-Label; Monocentric study. Patients will be enrolled to detect a 20% difference between the two groups on the primary outcome (50% or more of headache reduction by 12 months). For each medication type and research arm 20 patients will be selected: thus 80 patients will be enrolled for neuroradiological investigation.

Conditions

Chronic Migraine; Medication Overuse Headache

Keywords

Chronic Migraine; Medication Overuse Headache; Mindfulness; Pharmacological Prophylaxis; Neuroimaging; Neuroinflammation; Disability; Quality of Life; Depression; Anxiety

Outcome Measures

Primary Outcomes (1)

• Headache frequency reduction

  Percentage of patients achieving 50% or more of headache frequency reduction at 12-months compared to baseline assessed with headache diary.

  12 months

Secondary Outcomes (10)

• Neuroimaging pattern

  12 months

• Cost-efficacy

  3, 6, 12 months

• Health and disability

  3, 6, 12 months

• Disability

  3, 6, 12 months

• Change in Quality of life

  3, 6, 12 months

Study Arms (2)

MT group

EXPERIMENTAL

Education of patients, Pharmacological Prophylaxis prescribed based on patients' profile, and six group sessions of 45 minutes of mindfulness-based treatment.

Behavioral: Mindfulness; Drug: Prophylactic

MED group

OTHER

Education of patients followed by Pharmacological Prophylaxis, prescribed based on patients' profile (i.e. clinical features, previous failures and contraindications)

Drug: Prophylactic

Interventions

Mindfulness BEHAVIORAL

The experimental group will receive education, will be prescribed prophylaxis and will attend Mindfulness-based therapy sessions. The MINDFULNESS therapy consists in 6 weekly sessions, 45 minutes each. The main focus of the six mindfulness session will be the following: 1) introduction and meaning; 2) Focus on breath; 3) posture and body awareness; 4) meditation of sounds; 5) Guided imagery; 6) acceptance and awareness. During training, patients will be invited to close their eyes, assume a relaxed position, focus on their breathing and on the present to enhance awareness of current mind and body sensations. Patients will be trained in small groups (5-7 patients each) and guided by a specifically trained therapist. They will be educated to practice at home according to the instructions given by the therapist during the sessions.

MT group

Prophylactic DRUG

Control group will receive education on the use of pharmacological compounds for acute treatment and on healthy lifestyle habits (e.g. adequate sleep/wake pattern, eating and hydration, physical activity, avoidance of triggers) and will be prescribed prophylactic medications. The preventive compound will be chosen on the basis of clinical profile among the following categories: neuromodulators (e.g. topiramate or valproate), antidepressant (e.g. tricyclics or SSRIs) or others, e.g. beta-blockers.

MED group; MT group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic Migraine (migraine headaches on ≥15 days of migraine headache per month, for three consecutive months) associated to Medication overuse (Regular intake for \>3 months of analgesics on \>=15 days/month or of triptans, ergotamine, NSAID, opioids or multiple drugs on \>=10 days/month). Diagnoses are made according to the third version of the International Classification of Headache Disorders (code 1.3-Chronic Migraine; code 8.2-Medication Overuse Headache).

You may not qualify if:

• psychiatric comorbidities of psychotic area;
• pregnancy;
• comorbidity with secondary headaches (e.g. idiopathic intracranial hypertension);
• submitted to withdrawal from MO at least twice in the previous two years;
• attended any mindfulness-based therapy

Sponsors & Collaborators

• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: lead

Study Sites (1)

Fondazione IRCCS Istituto Neurologico C. Besta, Neuroalgology Unit

Milan, Milano, 20133, Italy

Location

Related Publications (2)

• Grazzi L, D'Amico D, Guastafierro E, Demichelis G, Erbetta A, Fedeli D, Nigri A, Ciusani E, Barbara C, Raggi A. Efficacy of mindfulness added to treatment as usual in patients with chronic migraine and medication overuse headache: a phase-III single-blind randomized-controlled trial (the MIND-CM study). J Headache Pain. 2023 Jul 14;24(1):86. doi: 10.1186/s10194-023-01630-0.

  PMID: 37452281 DERIVED

• Grazzi L, Raggi A, Guastafierro E, Passavanti M, Marcassoli A, Montisano DA, D'Amico D. A Preliminary Analysis on the Feasibility and Short-Term Efficacy of a Phase-III RCT on Mindfulness Added to Treatment as Usual for Patients with Chronic Migraine and Medication Overuse Headache. Int J Environ Res Public Health. 2022 Oct 29;19(21):14116. doi: 10.3390/ijerph192114116.

  PMID: 36360996 DERIVED

MeSH Terms

Conditions

Headache Disorders, Secondary; Neuroinflammatory Diseases; Depression; Anxiety Disorders

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 14, 2018
• Study Start: November 5, 2018
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2023
• Last Updated: January 23, 2025

Record last verified: 2025-01

Locations

IT (1)